1. Field of the Invention
The present invention relates generally to the fields of biomedical engineering, biochemistry and surgical procedures. More specifically, the present invention provides a device and methods using wound laminates and occlusive coatings suitable for sealing tissues or enhancing wound healing.
2. Description of the Related Art
Conventional methods of wound closure following surgery consist of applying sutures or staples to join two or more tissues that have been dissected. Various alternative methods have been developed to fasten tissues together without the use of a conventional staple or suture. Commercial electrosurgery and electrocautery devices, which employ heat, are often used for sealing external and internal wounds. Other ways for sealing vessels using other forms of electromagnetic energy, such as that produced by lasers, are known.
Tissue adhesives consisting of biomolecules, such as fibrin, currently are used to “glue” tissue-to-tissue. The results are often sub-optimal due to weak adherence and dissolution of the fibrin clot. Cyanoacrylates of various types, derived from instant bonding glues, e.g., SUPERGLUE™, also are used on tissue and available for use in the home, although currently they are approved only in the United States for external use. DERMABOND™, an approved topical skin adhesive, is 2-octyl cyanoacrylate with added colorant D&C Violet #2 for easy visualization. The package insert for this material warns that any inadvertent contact with any body tissue and any surfaces or equipment, such as latex gloves or stainless steel, should be avoided. The adhesive is applied by apposing the tissue edges with fingers or forceps and applying the liquid adhesive in several stroking motions not unlike that used with a paintbrush, allowing time to dry in between strokes.
Practically, there is a significant problem with the use of fast-setting skin adhesives. Bonding may result in unintentional bonding of human or inanimate applicators. During application of cyanoacrylate-based adhesives the care provider often glues his or her examination gloves to the patients. Unintentional bonding requires the bonded materials to be peeled apart potentially causing local trauma. Acetone is a solvent of cyanoacrylate that can help loosen the bond, but the use of acetone on an open wound can be problematic. Furthermore, DERMABOND™ is not indicated for use in high-tension skin areas, where it's holding force may be insufficient to maintain wound closure, or near the eyes where runoff of the glue may result in unintentional adhesion.
The inventors have recognized a need in the art for an improvement in the devices and methods used for joining tissues separated through surgery or through trauma. The prior art is deficient in the lack of fast-setting adhesives and the use thereof in minimizing the risk of unintentional bonding during use of these fast-setting adhesives. The present invention fulfills this longstanding need and desire in the art.